← Back to Search

Protein Kinase Inhibitor

Silmitasertib + Chemotherapy for Recurrent Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Age: Less than 30 years old at initial diagnosis

2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed/refractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study a new drug called silmitasertib, taken as a pill, along with approved drugs for solid tumors. The goals include finding the right dose of silmitasert

Who is the study for?

This trial is for young patients under 30 years old initially diagnosed with specific solid tumors like Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, or Liposarcoma that have not responded to treatment or have come back after treatment. Patients must have a confirmed diagnosis and meet certain criteria based on their type of cancer.

What is being tested?

The study tests Silmitasertib (a pill) combined with chemotherapy drugs Irinotecan, Temozolomide, and Vincristine in patients with relapsed or refractory solid tumors. It aims to find the right dose of Silmitasertib when used with these chemotherapies and assess its safety and effectiveness against the cancers.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related issues such as nausea, vomiting, hair loss, fatigue; plus any unknown risks from Silmitasertib since it's an investigational drug not yet approved by regulatory authorities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was diagnosed before turning 30.

Select...

My cancer is one of the specified types and has come back or didn’t respond to treatment.

Select...

My neuroblastoma has come back or didn't respond to treatment.

Select...

My neuroblastoma is classified as L2, MS, or M with MYCN amplification.

Select...

I am at least 547 days old and my cancer is at an advanced stage.

Select...

My Ewing sarcoma has come back or didn't respond to treatment.

Select...

My neuroblastoma has returned after completing standard treatment.

Select...

My high-risk neuroblastoma hasn't responded to at least 4 treatment cycles or has worsened.

Select...

I was diagnosed at any age with a specific stage of neuroblastoma that worsened without chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Phase I- Number of Participants with Dose Limiting Toxicities to determine RP2D

Phase II- Determine the Overall Response Rate (ORR) of Participants using INSS Response

Secondary study objectives

Number of participants with progression free survival (PFS) during study

Phase I- Determine the Overall Response Rate (ORR) of Participants using INSS Response

Phase II- Length of time that participants experience Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase II- Relapsed/refractory NeuroblastomaExperimental Treatment3 Interventions

Silmitasertib RP2D twice a day plus Irinotecan and Temozolomide

Group II: Phase II- Relapsed/refractory Ewing sarcomaExperimental Treatment4 Interventions

Silmitasertib RP2D twice a day plus Vincristine, irinotecan and temozolomide

Group III: Phase I- Dose level 2Experimental Treatment4 Interventions

Silmitasertib 800 mg/m2 twice a day plus Neuroblastoma: Regimen A: Irinotecan and Temozolomide Sarcoma: Regimen B: Vincristine, Irinotecan and Temozolomide

Group IV: Phase I- Dose level 1Experimental Treatment4 Interventions

Silmitasertib 600 mg/m2 twice a day plus Neuroblastoma: Regimen A: Irinotecan and Temozolomide Sarcoma: Regimen B: Vincristine, Irinotecan and Temozolomide

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Silmitasertib

2020

Completed Phase 2

~20

Irinotecan

2017

Completed Phase 3

~2590